Devices for assisting with advancement of catheters and related systems and methods

ABSTRACT

Disclosed herein is a catheter advancement device having an elongate shaft and a capsule attached to or integral with the shaft, and related methods for assisting with advancement of catheters such as cardiovascular guiding catheters while reducing damage to the inner wall of the blood vessel. Some capsules have a distal plug portion and a neck portion having a smaller diameter than the plug. Other capsules have a channel defined along the outer surface of the capsule. Some elongate shafts have an attachment tube disposed at or near the proximal end thereof.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims priority as a continuation application to U.S.application Ser. No. 16/672,708, filed Nov. 4, 2019, and entitled“Devices for Assisting with Advancement of Catheters and Related Systemsand Methods,” which claims the benefit under 35 U.S.C. § 119(e) to U.S.Provisional Application 62/756,184, filed Nov. 6, 2018 and entitled“Improved Catheter Advancement Device,” and further claims priority as acontinuation-in-part application to U.S. application Ser. No.15/499,194, filed Apr. 27, 2017 and entitled “Devices for Assisting withAdvancement of Catheters and Related Systems and Methods,” which claimsthe benefit under 35 U.S.C. § 119(e) to U.S. Provisional Application62/328,239, filed Apr. 27, 2016 and entitled “Devices for Assisting withAdvancement of Guiding Catheters and Related Systems and Methods,” allof which are hereby incorporated herein by reference in theirentireties.

FIELD

The various embodiments herein relate to advancement devices forassisting with advancement of a catheter through a blood vessel,including a tortuous or narrow blood vessel, while reducing the risk ofdamaging the inner wall of the blood vessel with the distal end of thecatheter.

BACKGROUND

A guiding catheter (or “sheath”) is a standard catheter that isgenerally a long tube with a pre-determined shape. It is typically usedto gain access to the vasculature—such as a coronary artery—by advancingthe catheter through the access point during an interventionalprocedure. The pre-determined, typically curved shape of the catheterfacilitates accessing a specific branch or other portion of thevasculature that requires such a curvature in the catheter.

One disadvantage of a pre-shaped, curved distal end of a catheter(including, but not limited to, a guiding catheter or sheath) is thatthe advancement of the catheter can be impeded by the distal endcontacting and damaging the inner wall of the vessel through which thecatheter is being advanced. For example, as depicted in FIG. 1A, thepre-shaped distal end 12 of the guiding catheter 10 can potentiallycontact the inner wall 16 of the blood vessel 14 (at the area A asshown) as the catheter 10 is advanced distally through the vessel 14(typically over a guidewire such as the guidewire depicted in FIGS. 1Band 1C, which can be, for example, a 0.035″ or 0.038″ guidewire),thereby scraping or otherwise causing damage to the inner wall 16. Thisscraping (or other damage) of the inner wall of the blood vessel by thecatheter distal end 12 is sometimes called a “razor effect.”

As best shown in FIG. 1B, one standard, known technique for overcomingthe “razor effect” has been the use of a balloon catheter, such as theballoon catheter 20 as shown in the figure. For example, in use, theballoon catheter 20 can be advanced through the inner lumen 24 of theguiding catheter 10 (or other type of catheter or sheath), positionedsuch that the balloon 22 is protruding from the distal end of thecatheter 10 such that a portion of the balloon 22 is positioned withinthe distal end of the catheter 10 and a portion extends out of thedistal end of the catheter 10, and then the balloon 22 is inflated. Oncethe balloon 22 is inflated, the guiding catheter 10 can be advancedthrough the blood vessel 14 with the balloon 22 positioned to preventdirect contact between the distal end of the catheter 10 and the innerwall 16 of the vessel 14, thereby preventing the “razor effect.” Oncethe catheter 10 is advanced to the desired position, the balloon 22 isdeflated and the balloon catheter 20 is withdrawn from the guidingcatheter 10 so that the guiding catheter 10 is ready for use. It isunderstood that any balloon catheter discussed herein can be any knownballoon catheter, including, for example, a percutaneous transluminalcoronary angioplasty (“PTCA”) balloon catheter.

One disadvantage of using a balloon catheter (such as catheter 20discussed above) to prevent the razor effect is the cost: ballooncatheters are expensive. Another disadvantage is that the positioning ofa balloon catheter at the distal end of the guiding catheter makes itdifficult to inject any contrast or other fluid through the guidingcatheter and past the inflated balloon of the balloon catheter. That is,the balloon must be deflated in order to allow for injection and thenre-inflated. An additional disadvantage is that most known ballooncatheters (including most PTCA balloon catheters) require the exchangeof guidewires in the middle of the procedure. That is, most knownballoon catheters in the required size range are only compatible with0.014″ guidewires and thus, during the procedure described above, thesurgeon is required to remove the 0.035″ or 0.038″ guidewire used toinsert the pre-shaped catheter and replace it with an 0.014″ guidewirein order to be able to introduce the known balloon catheter.

Another disadvantage relates to the use of a advancement device and thetension during introduction of the guide catheter between the need toattach the attachment device to the guide catheter and the need to beable to move the catheter in relation to the guidewire. That is, in useas best shown in FIG. 10 , the guiding catheter 10 is typicallypositioned within the blood vessel of the patient by first introducing aguidewire 18 and then advancing the catheter 10 over the stationaryguidewire 18. To accomplish this, the proximal valve 26 of the catheter10 has an open configuration such that the guidewire 18 can pass throughthe valve 26 while allowing the passage of as little fluid as possible(in contrast to its closed configuration in which the valve 26 isfixedly coupled to the guidewire 18 and creates a fluidic sealtherebetween). However, it is desirable to attach an advancement device(not shown) to the catheter 10 during advancement by closing the valve26 to attach it to the advancement device such that the advancementdevice cannot move in relation to the catheter 10 during advancement.Thus, the need to have the catheter 10 attached to an advancement devicecombined with the need to have the catheter 10 not attached to theguidewire 18 creates a complication.

Thus, there is a need in the art for an improved method and device foradvancing a guiding catheter.

BRIEF SUMMARY

Discussed herein are various catheter insertion or advancement devicesfor use in assisting with advancement of a catheter through a bloodvessel while reducing damage to the inner wall of the blood vessel.

In Example 1, a catheter advancement assistance device comprises anelongate shaft, a capsule fixedly attached to a distal end of theelongate shaft, and an attachment tube associated with a proximalportion of the elongate shaft. The capsule comprises a guidewire lumendefined through the capsule, and an outer diameter substantially similarto an inner diameter of a catheter such that the capsule is sized to bepositionable through the catheter.

Example 2 relates to the device according to Example 1, wherein theattachment tube further comprises a tube body, a lumen defined withinthe tube body, a distal opening defined in a distal end of the tubebody, wherein the distal opening is in fluidic communication with thelumen, and a proximal opening defined in a proximal end of the tubebody, wherein the proximal opening is in fluidic communication with thelumen.

Example 3 relates to the device according to Example 1, wherein theattachment tube is a compressible attachment tube.

Example 4 relates to the device according to Example 3, wherein thecompressible attachment tube comprises an elongate opening defined alonga length of the compressible attachment tube.

Example 5 relates to the device according to Example 1, wherein thecapsule further comprises a distal portion, and a neck extendingproximally from the distal portion, wherein the neck has a smallerdiameter than the distal portion.

Example 6 relates to the device according to Example 1, wherein theguidewire lumen has an inner diameter that is larger than an outerdiameter of a standard guidewire.

Example 7 relates to the device according to Example 1, wherein theguidewire lumen is sized to allow fluid to flow through the lumen when astandard guidewire is positioned therein.

Example 8 relates to the device according to Example 1, wherein thecapsule further comprises a channel defined longitudinally along anouter surface of the capsule.

Example 9 relates to the device according to Example 1, wherein thecapsule further comprises a lip formed around at least a portion of anouter circumference of the capsule.

Example 10 relates to the device according to Example 9, wherein the lipcomprises at least two lip segments formed around the outercircumference of the capsule.

Example 11 relates to the device according to Example 1, wherein thecapsule further comprises an expanded distal section, wherein theexpanded distal segment is substantially elastic, a non-expandedproximal section having a smaller diameter than the expanded distalsection, and a lip formed at a juncture between the expanded distalsection and the non-expanded proximal section, wherein the lip is formedaround at least a portion of a circumference of the capsule.

Example 12 relates to the device according to Example 1, wherein thecapsule further comprises a substantially elastic ridge formed around atleast a portion of an outer circumference of the capsule.

Example 13 relates to the device according to Example 12, wherein thesubstantially elastic ridge comprises at least two substantially elasticrig segments formed around the outer circumference of the capsule.

Example 14 relates to the device according to Example 1, wherein thecapsule further comprises a slot defined in a distal end of the capsule,whereby the distal end of the capsule is compressible.

Example 15 relates to the device according to Example 1, wherein thecapsule further comprises a void defined in a portion of the capsule,whereby an area of the capsule near the void is compressible.

In Example 16, a catheter advancement assistance device comprises a pushrod, a body fixedly attached to a distal end of the push rod, and acompressible attachment tube associated with a proximal portion of thepush rod. The body comprises a distal plug portion, a proximal neckportion, wherein the proximal neck portion has a smaller diameter thanthe distal plug portion, and a guidewire lumen defined through the body.

Example 17 relates to the device according to Example 16, wherein theguidewire lumen is sized to allow fluid to flow through the lumen when astandard guidewire is positioned therein.

Example 18 relates to the device according to Example 16, wherein thebody further comprises a channel defined longitudinally along an outersurface of the body.

Example 19 relates to the device according to Example 16, wherein thebody further comprises a seating component formed around at least aportion of an outer circumference of the capsule.

Example 20 relates to the device according to Example 19, wherein theseating component comprises a lip or a ridge.

Example 21 relates to the device according to Example 16, wherein thecompressible attachment tube comprises an elongate opening defined alonga length of the compressible attachment tube.

In Example 22, a method of assisting advancement of a catheter through ablood vessel comprises inserting an advancement assistance device into alumen of the catheter, the advancement assistance device comprising anelongate shaft, a body fixedly attached to a distal end of the elongateshaft, and an attachment tube associated with a proximal portion of theelongate shaft. The body comprises a distal plug portion, a proximalneck portion, wherein the proximal neck portion has a smaller diameterthan the distal plug portion, and a guidewire lumen defined through thebody. The method further comprises urging the advancement assistancedevice distally into the lumen of the catheter until a distal portion ofthe distal plug portion extends out of a distal opening in the catheter,a proximal portion of the distal plug portion is positioned within thelumen of the catheter, and the attachment tube is disposed within aproximal valve of the catheter, attaching the proximal valve to theattachment tube, urging the catheter distally into the blood vessel to atarget site over a guidewire, and retracting the advancement assistancedevice from the catheter.

Example 23 relates to the method according to Example 22, furthercomprising urging the advancement assistance device distally until thedistal plug portion extends out of the distal opening, whereby space isprovided between the body and the distal opening, urging contrastsolution distally through the catheter and through the space between thebody and the distal opening and into the blood vessel, and urging theadvancement assistance device proximally until the distal portion of thedistal plug portion extends out of the distal opening in the catheterand the proximal portion of the distal plug portion is positioned withinthe lumen of the catheter.

In Example 24, a method of assisting advancement of a catheter through ablood vessel comprises inserting an advancement assistance device into alumen of the catheter, the advancement assistance device comprising anelongate shaft, a body fixedly attached to a distal end of the elongateshaft, the body comprising a guidewire lumen defined through the body,and an attachment tube associated with a proximal portion of theelongate shaft. The method further comprises urging the advancementassistance device distally into the lumen of the catheter until a distalportion of the body extends out of a distal opening in the catheter, aproximal portion of the body is positioned within the lumen of thecatheter, and the attachment tube is disposed within a proximal valve ofthe catheter, attaching the proximal valve to the attachment tube,urging the catheter distally into the blood vessel to a target site overa guidewire, and retracting the advancement assistance device from thecatheter.

Example 25 relates to the method according to Example 24, furthercomprising urging contrast solution distally through the catheter andthrough the guidewire lumen and into the blood vessel.

Example 26 relates to the method according to Example 24, wherein thebody further comprises a channel defined longitudinally along an outersurface of the body.

Example 27 relates to the method according to Example 26, furthercomprising urging contrast solution distally through the catheter andthrough the channel and into the blood vessel.

Example 28 relates to the method according to Example 24, wherein thebody further comprises a seating component formed around at least aportion of an outer circumference of the body.

Example 29 relates to the method according to Example 28, wherein theseating component comprises a lip or a ridge.

Example 30 relates to the method according to Example 28, furthercomprising urging the advancement assistance device distally through thelumen of the catheter until the seating component is urged out of thedistal opening in the catheter, and urging the advancement assistancedevice proximally until the seating component contacts the distal end ofthe catheter.

Example 31 relates to the method according to Example 24, wherein theattachment tube is a compressible attachment tube, wherein the attachingthe proximal valve to the attachment tube causes the compression of thecompressible attachment tube.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a cross-sectional view of a known catheter being advancedthrough a blood vessel.

FIG. 1B is a cross-sectional view of a known balloon catheter positionedwithin a known catheter.

FIG. 10 is a cross-sectional view of a known catheter with a proximalvalve.

FIG. 2 is a cross-sectional side view of a catheter advancement devicepositioned within a catheter, according to one embodiment.

FIG. 3A is a cross-sectional side view of a distal portion of a plug ofa catheter advancement device, according to one embodiment.

FIG. 3B is a cross-sectional side view of a distal portion of a plug ofa catheter advancement device, according to another embodiment.

FIG. 4 is a cross-sectional side view of a catheter advancement devicehaving visualization markers and positioned within a catheter, accordingto one embodiment.

FIG. 5 is a cross-sectional side view of a catheter advancement deviceextending out of a distal end of a catheter, according to oneembodiment.

FIG. 6 is a cross-sectional side view of a catheter advancement devicepositioned within a catheter, according to another embodiment.

FIG. 7A is a cross-sectional side view of a catheter advancement devicepositioned within a catheter, according to a further embodiment.

FIG. 7B is a cross-sectional front view of the catheter advancementdevice of FIG. 7A.

FIG. 8 is a cross-sectional side view of a catheter advancement devicepositioned within a catheter, according to yet another embodiment.

FIG. 9 is a cross-sectional side view of a catheter advancement devicepositioned within a catheter, according to an alternative embodiment.

FIG. 10A is a cross-sectional side view of a plug, according to anotheralternative embodiment.

FIG. 10B is a cross-sectional front view of the plug of FIG. 10A.

FIG. 11A is a cross-sectional side view of a plug, according to anotheralternative embodiment.

FIG. 11B is a further cross-section side view of the plug of FIG. 11A.

FIG. 12 is a cross-sectional side view of a method of making a catheteradvancement device, according to one embodiment.

FIG. 13A is a cross-sectional side view of a catheter advancement devicehaving an attachment tube, according to one embodiment.

FIG. 13B is a cross-sectional side view of the catheter advancementdevice of FIG. 13A disposed within a guiding catheter, according to oneembodiment.

FIG. 14 is an expanded side view of an attachment tube on a catheteradvancement device, according to one embodiment.

FIG. 15A is an expanded side view of another attachment tube on acatheter advancement device, according to a further embodiment.

FIG. 15B is a cross-sectional view along the longitudinal axis of theattachment tube of FIG. 15A, according to one embodiment.

FIG. 16 is a cross-sectional side view of another catheter advancementdevice having an attachment tube disposed within a guiding catheter,according to another embodiment.

DETAILED DESCRIPTION

The various embodiments disclosed or contemplated herein relate tocatheter assertion or advancement devices and related methods forassisting in the advancement of a cardiovascular catheter through ablood vessel, including, for example, a cardiovascular guiding catheteror sheath with a curved shape, while reducing or eliminating the risk ofdamage to the blood vessel inner wall. The various embodiments include adistal capsule and a push rod attached thereto. Alternative embodimentsinclude an attachment tube disposed at a proximal end of the push rod.

FIG. 2 depicts, according to one embodiment, a catheter advancementdevice 30 (also referred to as an “insertion device,” a “catheterinsertion device,” or an “advancement device”) for assisting with or usein advancing a catheter, such as, for example, a guiding catheter. Thedevice 30 has a capsule (also referred to herein as a “body” or“insertion body”) 32 with a partially rounded distal end 33 and a pushrod (also referred to herein as an “elongate component”) 34 coupledthereto. The capsule 32 has a lumen 36 defined therethrough that isconfigured to allow for passage of a guidewire 38 therethrough as shown.The push rod 34 is embedded in or otherwise fixedly coupled to thecapsule 32 such that appropriate forces can be applied at the proximalend of the push rod 34 by a user (such as a surgeon or medicalprofessional) to urge the capsule 32 distally or proximally during use.

In use as shown in the figure, the distal end of the capsule insertiondevice 30 can be advanced through the inner lumen 42 of a guidingcatheter 40 (by a user holding the proximal end of the rod 34) andpositioned such that the capsule 32 is protruding from the distal end ofthe catheter 40. In this position, a portion of the capsule 32 ispositioned within the distal end of the catheter 40 and a portionextends out of the distal end of the catheter 40. At this point, theuser locks the device 30 into position in relation to the catheter 40.That is, according to one embodiment, the user attaches the proximal endof the rod 34 to the catheter 40 in any known fashion. For example, inone specific implementation, a known locking mechanism at the proximalend of the catheter 40 (such as a Tuohy-Borst adapter, for example) isused to lock the device 30 to the catheter 40. Alternatively, thelocking mechanism can be a proximal valve similar to the proximal valve26 discussed above in the Background. As such, the advancement device 30is locked or otherwise attached to the catheter 40 such that the devicecannot move translationally in relation to the catheter 40. Once thecapsule 32 is positioned as shown (and, in some cases, the device 30 islocked in place), the guiding catheter 40 can be advanced through ablood vessel with the capsule 32 positioned to prevent direct contactbetween the distal end of the catheter 40 and the inner wall of thevessel, thereby preventing the “razor effect.” Once the catheter 40 isadvanced to the desired position, the capsule catheter 30 is withdrawnfrom the guiding catheter 40 by a user pulling the push rod 34 in theproximal direction so that the guiding catheter 40 is ready for use.

The capsule body 32 can be a solid body with a lumen 36 definedtherethrough as shown. Alternatively, in the various embodimentsdisclosed or contemplated herein, the capsule (such as capsule 32) canbe any component or body that can be inserted through a guiding catheterand positioned to reduce or eliminate the razor effect. According tosome embodiments, the capsule is non-inflatable. In certainimplementations, the capsule has a substantially cylindrical shape.Alternatively, the capsule can have any known shape that allows it to beadvanced through a catheter and positioned out of the distal end thereofas described herein.

In certain embodiments, the outer diameter of the body 32 can vary orhave specific features as described herein depending on the desiredfunctionality of the body 32. In this specific implementation, thecapsule 32 has a larger distal portion (also referred to herein as a“plug,” “distal plug,” or “distal body”) 44 and a smaller proximalportion (also referred to as a “neck,” or “tail”) 46. The distal body 44has a larger diameter than the neck 46. In the embodiment as shown, thecapsule 32 is a single integral body 32 having the larger distal portion44 and the smaller proximal portion 46 as shown. Alternatively, thecapsule 32 can have two separate portions coupled together: the firstlarger distal portion 44 and the second smaller proximal portion 46attached thereto.

In one embodiment, the capsule 32 has an outer diameter ranging fromabout 0.05 inches to about 0.3 inches. Alternatively, the outer diameterranges from about 0.065 inches to about 0.105 inches. In a furtherimplementation, the capsule 32 has an outer diameter that fits snuglywithin (makes contact with the inner wall of) any cardiovascular guidingcatheter, such as, for example, the Medtronic Launcher™ or CordisVistaBrite™ 5 French to 8 French guiding catheters. Further, the capsule32 can be sized to fit snugly within any guiding catheter having anysize ranging from about 4 French to about 22 French. It is understoodthat the “snug” fitting in this embodiment and in any other capsuleembodiment disclosed or contemplated herein is a fitting of the capsule(such as capsule 32) within the catheter such that the outer surface ofthe capsule makes sufficient contact with the inner wall of the catheterto prevent passage of fluid therebetween.

In one embodiment, any capsule embodiment disclosed or contemplatedherein (such as capsule 32) is made of a polymeric material. Forexample, the capsule can be made of polyethylene, Pebax, Nylon,polyester, or any other polymeric material or combination thereof.Alternatively, the capsule can also be made of metal or any other knownmaterial that can be used for medical devices. In a furtherimplementation, the capsule (such as capsule 32) can be made of two ormore materials. More specifically, in certain embodiments, the capsulecan be made of two or more materials having differing stiffness and/orflexibility such that one portion of the capsule (such as the distalend, for example) is stiffer, more rigid, and/or less flexible thananother portion. In other words, the two or more materials can be usedto create a capsule that has stiffness, rigidity, or flexibility thatvaries along the length of the capsule.

Further, any capsule embodiment disclosed or contemplated herein (suchas capsule 32) can also have a coating disposed on the outer surface ofthe capsule to increase the lubricity of the capsule. In certainimplementations, the coating can be hydrophilic or hydrophobic.

According to any embodiment disclosed or contemplated herein, the pushrod (such as push rod 34) can be made of metal. Alternatively, the pushrod can be made of any known material that can be used to make anelongate component with sufficient column strength such that thecomponent can be used to advance a capsule through the lumen of aguiding catheter while also having some flexibility. It is understoodthat the push rod (also referred to as a “proximal elongate member” or“control rod” or “manipulation rod”) in any embodiment herein can be anyelongate component that is coupled to the proximal end of the capsuleand can withstand the forces necessary for a user to urge the roddistally or proximally to move the capsule through a guiding catheter asdescribed herein. In certain alternative implementations, the push rodcan be integral with the capsule. Further, various embodiments include apush rod and capsule formed together of the same materials such that thepush rod is integral with the capsule.

It is understood that the capsule (such as capsule 32) can take avariety of shapes, so long as the capsule can be positioned out of thedistal end of a guiding catheter as described herein and help withadvancement thereof through a blood vessel. For example, capsule 50 asbest shown in FIG. 3A according to one embodiment has a tapered distalend 52, while capsule 54 as best shown in FIG. 3B in accordance withanother implementation has a rounded distal end 56. According to furtheralternatives, the capsule can have a distal end with an angled shape, aspherical shape, or any other known shape that helps to advance theguiding catheter when the capsule is positioned out of the distal end ofthe guiding catheter.

In certain implementations, any advancement device disclosed orcontemplated herein can have at least one visualization marker disposedon the device. One exemplary embodiment is depicted in FIG. 4 , in whichthe capsule insertion device 60 has two visualization markers 64A, 64B.The first visualization marker 64A is disposed at or near the distal endof the distal plug 62A of the capsule 62, while the second marker 64B isdisposed on the neck 62B of the capsule 62. Alternatively, any deviceembodiment can have one marker or three or more markers. It isunderstood that the markers 64A, 64B (and any markers incorporated intoany capsule insertion device embodiment as disclosed or contemplatedherein) can be radiopaque markers. Alternatively, the markers (such asmarkers 64A, 64B) can be made of any known material for a visualizationmarker. The markers 64A, 64B—and any such markers used in any embodimentherein—can be used to assist a user with positioning the capsuleinsertion device 60.

In use, it is often necessary or helpful to inject contrast solutionthrough the lumen of a guiding catheter and into the vasculature of thepatient to assist with placement of the guiding catheter. As discussedabove, if a known balloon catheter is being used to assist withadvancement of the guiding catheter, the process for injecting thecontrast solution is complicated by the presence of the balloon, whichmust be deflated in order to inject the solution. However, as best shownin FIGS. 5-7B, various embodiments of the capsule device disclosed orcontemplated herein eliminate those complications.

For example, in one implementation as shown in FIG. 5 , the catheteradvancement device 80 has a capsule 82 with a distal body 82A and a neck82B similar or identical to the capsule 32 described above. To injectcontrast solution after the capsule 82 has been positioned at the distalend of the guiding catheter 84 (for advancing the catheter 84 throughthe vasculature as described above), the capsule device 80 is urgeddistally (by a user urging the proximal end of the push rod 90 distally)such that the body 82A of the capsule 82 is urged distally out of thelumen 86 of the guiding catheter 84 as shown in FIG. 5 . Morespecifically, the capsule 82 is urged distally until the body 82A isurged out of the lumen 86 such that space is created between the opening88 of the guiding catheter 84 and the body 82A, thereby making itpossible for contrast to exit from the opening 88 as represented byarrows A. In certain implementations such as that shown in FIG. 5 , thecapsule 82 need not be urged distally so far that the neck 82B alsoexits the lumen 86. Instead, the smaller diameter of the neck 82B allowsfor sufficient space between the neck 82B and the opening 88 to allowfor contrast to exit the lumen 86.

In an alternative embodiment, as shown in FIG. 6 , the capsule 102 neednot be advanced distally out of the lumen 110 of the guiding catheter108. More specifically, one implementation of a capsule device 100 has acapsule 102 with a lumen 104 defined therein that has a larger innerdiameter than is necessary to accommodate solely a guide wire 106. Assuch, the lumen 104 has a sufficient inner diameter to provide space forthe guide wire 106 while also having sufficient additional space toallow for contrast solution to flow distally out of the guiding catheter108 through the capsule lumen 104 and into the vasculature asrepresented by arrows B. In one embodiment, the inner diameter of thelumen 104 ranges from about 0.01 inches to about 0.05 inches.Alternatively, the inner diameter ranges from about 0.02 inches to about0.04 inches. In a further implementation, the inner diameter of thelumen 104 is sufficiently large to receive a guidewire of any sizeranging from 0.01 inches to 0.04 inches and still has at least a 0.004inch diameter of space between the guidewire and the inner wall of thelumen 104.

In use, once the capsule device 100 is positioned at the distal end ofthe guiding catheter 108 such that the capsule 102 is positioned asdesired for advancing the catheter 108, the capsule 102 need not bemoved in order to inject the contrast solution. Instead, the capsule 102can remain in place while the contrast solution flows distally throughthe lumen 110 of the guiding catheter 108 and through the lumen 104 ofthe capsule 102 and out into the vasculature.

Another configuration as depicted in FIGS. 7A and 7B also allows forcontrast solution injection without moving the capsule device. In thisimplementation, the capsule device 120 has a capsule 122 with a channel(also referred to as a “slot” or “trough”) 126 defined longitudinallyalong the outer surface 124 of the capsule 122 (as best shown in FIG.7B). As such, the channel 126 defines a space between the capsule 122and the inner surface of the lumen 130 of the guiding catheter 128through which contrast solution can flow distally out into thevasculature as represented by arrows C. In one embodiment, the channel126 has an inner diameter ranging from about 0.002 inches to about 0.02inches. Alternatively, the inner diameter ranges from about 0.004 inchesto about 0.008 inches. In use, once the capsule device 120 is positionedat the distal end of the guiding catheter 128 such that the capsule 122is positioned as desired for advancing the catheter 128, the capsule 122need not be moved in order to inject the contrast solution. Instead, thecapsule 122 can remain in place while the contrast solution flowsdistally through the lumen 130 of the guiding catheter 128 and throughthe channel 126 of the capsule 122 and out into the vasculature. It isunderstood that, according to various alternatives, the channel 126 canbe any feature or configuration on the capsule 122 or the outer surface124 thereof that allows fluid flow between the capsule 122 and the innerwall of the lumen 130.

Both the larger lumen 104 of the capsule device 100 embodiment and thechannel 126 of the capsule device 120 implementation make it easy for auser to inject contrast solution, as discussed above. In addition, thesetwo embodiments can also assist with limiting contrast fluid use.Injection of excess contrast fluid into the vasculature of a patientduring an interventional procedure can cause health issues for thepatient, including contrast-induced nephropathy. The lumen 104 of apredetermined diameter in the device 100 embodiment or the channel 126of a predetermined depth or diameter in the device 120 embodiment bothprovide mechanisms for injecting solution in known, more limited amountsthan those injected when using a balloon catheter as described above.

In certain alternative implementations, another capsule is provided—foruse with any of the capsule device embodiments disclosed or contemplatedherein—that has a seating component defined or disposed around an outersurface of the capsule that can assist with positioning the capsule inrelation to the guiding catheter during use and further can create asmoother or more streamlined transition from the outer surface of thecapsule to the outer surface of the guiding catheter in which thecapsule is positioned. It is understood that any of the seatingcomponents disclosed or contemplated herein can be defined or disposedaround the entire 360 degree circumference of the capsule.Alternatively, any such components can be defined or disposed aroundonly a portion of the circumference of the capsule. In a furtherembodiment, any such seating component can be defined or disposedintermittently around the circumference of the capsule such that thereare two or more seating components disposed or defined thereon such thatthey are positioned at different locations along and around thecircumference thereof.

One example of such a capsule is depicted in FIG. 8 , which shows oneembodiment of a capsule 140 having a seating component (or “seatingfeature”) 144. In this specific example, the seating component 144 is alip 144 created by the capsule 140 having an expanded section 142 (whichis a portion of the capsule 140 that has an increased diameter incomparison to the rest of the capsule 140). That is, the lip 144 isformed at the juncture of the expanded section 142 and the non-expandedsection of the capsule 140. As discussed above, the lip 144 can extendaround the entire circumference, can extend around a portion of thecircumference, or can constitute two or more lips 144 that are disposedor defined intermittently around the circumference. In one embodiment,the expanded section 142 is a portion of the body 148 of the capsule140. Alternatively, the expanded section 142 can be the body itself (notshown), and the transition from the body (not shown) to the neck (notshown) constitutes the seating component. The expanded section 142 hasan outer diameter that is substantially similar to or the same as theouter diameter of the guiding catheter 146. In certain embodiments, theexpanded section 142 or the entire capsule 140 has sufficient elasticityto allow for deformation of the expanded section 142 such that thecapsule 140 can be advanced through the guiding catheter 146 despite theexpanded section 142 having an outer diameter that is larger than theinner diameter of the guiding catheter 146 lumen. Regardless of thespecific embodiment of the capsule with the seating component (such asseating component 144), it is understood that the capsule 140 has atleast a portion of its outer surface that fits snugly within thecatheter as described elsewhere herein such that no fluid can passbetween the outer surface of the capsule 140 and the inner surface ofthe catheter.

In use, the capsule 140 is advanced distally through the guidingcatheter 146 and positioned out of the distal opening 150 of the guidingcatheter 146 according the same procedure used for all the capsuledevice embodiments herein. As mentioned above, the capsule 140 has anexpanded section 142 that has elastic characteristics that allow for thesection 142 to deform sufficiently as the capsule 140 is advancedthrough the guiding catheter to allow for passage of the capsule 140despite the expanded section 142 having a greater diameter than theinner diameter of the lumen of the guiding catheter 146. As the expandedsection 142 of the capsule 140 is urged out of the opening 150 at thedistal end of the guiding catheter 146, the expanded section 142 expandsback to its natural diameter, thereby causing formation of the lip 114.The user can then urge the capsule 140 back in a proximal direction—viathe push rod (not shown)—until the lip 114 is in contact with theguiding catheter 146, thereby confirming for the user via increasedresistance that the capsule 140 is in the desired position in relationto the guiding catheter 146. It is understood that the user must beaware that she or he cannot use so much force that the expanded section142 deforms and the capsule 140 is urged proximally past the desiredcapsule 140 position. Once the capsule 140 is positioned as desired, itcan be seen in FIG. 8 that the expanded section 142 has a diameter thatis substantially similar to the outer diameter of the guiding catheter146, thereby reducing the risk of the distal end of the guiding catheter146 making contact with an inner wall of a blood vessel wall duringadvancement of the guiding catheter 146. Once the capsule 140 ispositioned, the user then advances the guiding catheter 146 via the pushrod (not shown).

Another example of a capsule with a seating component is depicted inFIG. 9 , which shows a capsule 160 having a seating component 162. Inthis specific example, the seating component 162 is a ridge 162 formedor disposed on the outer surface of the capsule 160. As discussed above,the ridge 162 can extend around the entire circumference, can extendaround a portion of the circumference, or can constitute two or moreridges 162 that are disposed or defined intermittently around thecircumference. The ridge 162 has an outer diameter that is substantiallysimilar to or the same as the outer diameter of the guiding catheter164. In certain embodiments, the ridge 162 or the entire capsule 160 hassufficient elasticity to allow for deformation of the ridge 162 suchthat the capsule 160 can be advanced through the guiding catheter 164despite the ridge 162 having an outer diameter that is larger than theinner diameter of the guiding catheter 164 lumen. As with all capsuleimplementations herein, regardless of the specific embodiment of thecapsule with the seating component (such as seating component 162), itis understood that the capsule 160 has at least a portion of its outersurface that fits snugly within the catheter as described elsewhereherein such that no fluid can pass between the outer surface of thecapsule 160 and the inner surface of the catheter.

In use, the capsule 160 is advanced distally through the guidingcatheter 164 and positioned out of the distal opening 166 of the guidingcatheter 164 according the same procedure used for all the capsuledevice embodiments herein. As mentioned above, the ridge 162 on thecapsule 160 has elastic characteristics that allow for the ridge 162 todeform sufficiently as the capsule 160 is advanced through the guidingcatheter 164 to allow for passage of the capsule 160 despite the ridge162 having a greater diameter than the inner diameter of the lumen ofthe guiding catheter 164. As the ridge 162 of the capsule 160 is urgedout of the opening 166 at the distal end of the guiding catheter 164,the ridge 162 expands back to its natural diameter. The user can thenurge the capsule 160 back in a proximal direction until the ridge 162 isin contact with the guiding catheter 164, thereby confirming that thecapsule 160 is in the desired position in relation to the guidingcatheter 164. It is understood that the user must be aware that the usercannot use so much force that the ridge 162 deforms and the capsule 160is urged proximally past the desired capsule 160 position. Once thecapsule 160 is positioned as desired, it can be seen in FIG. 9 that theridge 162 has a diameter that is substantially similar to the outerdiameter of the guiding catheter 164, thereby reducing the risk of thedistal end of the guiding catheter 164 making contact with an inner wallof a blood vessel wall during advancement of the guiding catheter 164.Once the capsule 160 is positioned, the user then advances the guidingcatheter 164.

In certain implementations in which the capsule has a seating component(such as the seating components 144, 162 described above, for example)or similar feature, the deformation or partial collapse of the capsulemakes it possible for the capsule to advance through the guidingcatheter as discussed above. In one exemplary embodiment as shown inFIGS. 10A and 10B, instead of the capsule having elasticity as describedabove, a capsule 180 is provided that is a deformable or collapsiblecapsule 180. That is, the capsule 180 has a slot 182 defined in thedistal end of the capsule 180 along the length of the capsule 180 thatalso has a seating component 184 (similar to one of the seatingcomponents 144, 162 described above). In use, the slot 182 allows forthe capsule 180 to be deformed or have a smaller diameter as it isadvanced through a guiding catheter, similar to the use of the capsules140, 160 discussed above.

In another embodiment, a capsule 190 is provided that is collapsible ordeformable as a result of an opening 192 defined at a distal portion ofthe capsule along the length of the capsule 190 that also has a seatingcomponent 194. In use, the opening 192 allows for the capsule 190 to bedeformed or have a smaller diameter as it is advanced through a guidingcatheter, similar to the use of the capsules 140, 160 discussed above.

As discussed above, it is understood that the seating components 184,194 described above with respect to FIGS. 10A-11B can extend around theentire circumference, can extend around a portion of the circumference,or can constitute two or more such components that are disposed ordefined intermittently around the circumference.

The various catheter insertion device embodiments disclosed orcontemplated herein can be made in any number of known ways. In oneembodiment as shown in FIG. 12 , a capsule 200 can be formed using aninjection molding process. In this process, the starting point is aninner tube 202, with the capsule 200 being injection molded over theinner tube 202. In certain implementations in which the capsule 200 hastwo marker bands 204A, 204B, the marker bands 204A, 204B are disposedover the inner tube 202 before the capsule 200 is injected moldedthereon such that the material for the capsule 200 is injection moldedonto the marker bands 204A, 204B, thereby resulting in the marker bands204A, 204B being embedded in the capsule 200. Further, the push rod 206can be embedded in the capsule 200 in a similar fashion. That is, thepush rod 206 can be positioned along the inner tube 202 such thatinjection molding of the capsule 200 results in the push rod 206 beingembedded therein.

Other advancement device implementations include an attachment tubedisposed at a proximal end of the push rod to allow for attaching theadvancement device to the guiding catheter while the catheter can beadvanced over a guidewire.

For example, FIG. 13A depicts, according to one embodiment, anothercatheter advancement device 220 for assisting with or use in advancing acatheter, such as, for example, a cardiovascular guiding catheter. Aswith the other advancement device embodiments disclosed herein, thedevice 220 has a capsule 222 and a push rod (also referred to herein asan “elongate component”) 224 coupled thereto. The capsule 222 can have alumen 226 defined therethrough that is configured to allow for passageof a guidewire (not shown) therethrough. The various components of thedevice 220 are substantially similar to the various components describedin the other device embodiments above and can incorporate any of thevarious alternative components and/or features thereof.

In addition, the push rod 224 in this implementation has an attachmenttube (also referred to as a “coupling tube”) 228 attached at a proximalend of the push rod 224 as shown such that a catheter valve (includingany known valve on any known catheter as discussed elsewhere herein) canattach to the attachment tube 228 as desired and a guidewire can bemoveably disposed therethrough. That is, the attachment tube 228 definesa lumen 230 disposed through the tube 228 as shown that is sized toslidably receive a guidewire.

In one embodiment, the lumen 274 in the tube 270 (or any lumen of anyattachment tube disclosed or contemplated herein) has an inner diameterranging from about 0.008 inches to about 0.040 inches. Alternatively,the inner diameter ranges from about 0.014 inches to about 0.030 inches.In a further alternative, the tube 270 is sized such that the lumen 274can receive any known cardiovascular guidewire ranging in size fromabout 0.01 inches to about 0.04 inches.

In use, as best shown in FIG. 13B, according to one implementation, theadvancement device 220 can be disposed in a catheter 232. The knowncatheter 232 has a known proximal valve 234, which is a Toughy-borstvalve or any known sealable valve. It is understood that the catheter232 can be any known cardiovascular catheter as discussed elsewhereherein. The attachment tube 228 is disposed along the length of the pushrod 224 such that when the device 220 is disposed within the catheter232 as shown with the capsule 222 extending partially out of the distalend of the catheter 232, the attachment tube 228 is disposed through thevalve 234 of the catheter 232 (similar to valve 26 discussed above).Further, the attachment tube 228 can receive a guidewire 236 in thelumen 230 of the attachment tube 228 when the catheter 232 andadvancement device 220 are disposed over the guidewire 236 as shown. Asa result, the valve 234 of the catheter 232 can be removably coupled tothe attachment tube 228 (via any known mechanism that such a valve 234is attached to a device disposed therethrough) such that the advancementdevice 220 is attached to the catheter 232 and thus both are advancedtogether (such that the advancement device 220 does not move axially inrelation to the catheter 232) while the guidewire 236 can be slidablydisposed through the lumen 230 of the tube 228 such that the catheter232 and device 220 can be moved in relation to the guidewire 236. Inother words, the attachment tube 228 makes it possible for theadvancement device 220 to be attached to the catheter 232 via thecoupling of the catheter valve 234 to the tube 228 while the valve 234is not attached to the guidewire 236 (because the guidewire 236 isslidably disposed through the tube 228).

One specific embodiment of an attachment tube 250 that can beincorporated into any advancement device as disclosed or contemplatedherein is depicted in FIG. 14 , in accordance with one implementation.The tube 250 is coupled to a proximal end of a push rod 256 and has anelongate tubular body 252 that defines a lumen 254 as shown. The tubularbody 252 has a distal opening 258 and a proximal opening 260, both ofwhich are in fluidic communication with the lumen 254. In thisimplementation, the tubular body 252 is a substantially unitary body 252having no substantial openings along the length of the body 252. As withthe other attachment tube embodiments disclosed or contemplated herein,the tubular body 252 is configured to be disposed through a cathetervalve (such as valve 234 discussed above) such that the valve can beattached to the body 252.

Another embodiment of an attachment tube 270 that can be incorporatedinto any advancement device as disclosed or contemplated herein isdepicted in FIGS. 15A and 15B. The tube 270 is coupled to a push rod 276and has substantially the same features and characteristics as the tube250 discussed above, and thus the description of the similar componentsand features above apply equally to this tube 270 embodiment as well,except as described herein. Additionally, in this specificimplementation, the tube 270 is a compressible tube 270. The specificcompressible tube 270 embodiment as shown has an elongate opening 282defined along at least a portion of the length of the body 272. Morespecifically, in the specific embodiment depicted in FIGS. 15A and 15B,the elongate opening 282 is a slot 282 that extends along the entirelength of the body 272 from the distal opening 278 to the proximalopening 280. The tubular body 272 and slot 282 are configured such thatthe body 272 can be disposed through a catheter valve (such as valve 234discussed above) such that when the valve is clamped down on the tubularbody 272, the body 272 is compressed as a result of the slot 282 beingcollapsed by the valve such that the two opposing sides of the body 272that define the slot 282 are urged toward each other.

In one embodiment, the slot 282 has a width that ranges from about 0.004inches to about 0.03 inches. Alternatively, the slot 282 has a widthranging from about 0.01 inches to about 0.02 inches. In a furtherembodiment, the slot 282 is gap in the circumference of the body 272such that the gap constitutes a percentage of the total circumference ofthe body 272 ranging from about 4 percent to about 25 percent.Regardless of the size of the slot 282, it is understood that the terms“attachment tube” and “tube” are intended herein to encompass anytubular structure having any sized slot, gap, slit, or opening definedtherein, including a tubular structure having a gap that constitutes asmuch as 25 percent of the circumference of the structure.

Alternatively, instead of extending along the entire length of the body272, the slot 282 can extend along a portion of the length of the body272. In a further embodiment, the opening 282 can be any opening of anyshape or configuration that allows for compression of the tubular body272 when the valve (such as valve 234, for example) is clamped downthereon. According to another implementation, any opening 282 extendingalong the entire length of the body 272 can not only provide compressivequalities to the body 272, but can also assist with positioning aguidewire (such as guidewire 284 as discussed below) into the lumen 274of the tube 270 via the opening 282. That is, rather than having tothread a guidewire into one of the openings 278, 280 and thereby throughthe entire length of the lumen 274, a user can insert the guidewire intothe lumen 274 through the opening 282.

Regardless of the exact size, shape, and configuration of the opening282, the body 272 of the compressible tube 270 has some degree ofcompliance that allows for the body 272 to be compressed such that thelumen 274 defined therein is reduced in size (or inner diameter) as aresult of the compression. Thus, as best shown in FIG. 15B, the lumen274 in the uncompressed state has sufficient size such that there isspace between the inner wall of the lumen 274 and the guidewire 284. Assuch, the body 272 can be compressed by some amount such that the innerdiameter of the lumen 274 is reduced while still providing sufficientspace between the inner wall of the lumen 274 and the guidewire 284 suchthat the guidewire 284 can still move axially in relation to the body272 while minimizing the amount of blood loss through the lumen 274 byminimizing the space between the inner wall of the lumen 274 and theguidewire 284.

In another alternative embodiment, the tube 270 and any othercompressible tube embodiment as disclosed or contemplated herein canhave any structure or feature that provides or allows for compression ofthe tube 270.

In accordance with another embodiment as depicted in FIG. 16 , theadvancement device 300 has an attachment tube 302 with a blockingprotrusion 304 extending from a proximal end thereof. In thisimplementation, the blocking protrusion 304 is a disk 304 disposed at ornear the proximal end of the tube 302. Alternatively, the blockingprotrusion 304 can be a lip, a rim, or any other known structuralfeature or component that forms a radial protrusion or extension that isdisposed at a proximal end of the attachment tube 302 and has an outerdiameter or dimension that is greater than the inner diameter of thevalve 308 of the catheter 306, thereby preventing the blockingprotrusion 304 from passing into or through the valve 308. As such, theblocking protrusion 304 can be incorporated into the attachment tube 302such that the advancement device 300 cannot be inadvertently advanceddistally so far that the attachment tube 302 passes through the valve308.

It is understood that any of the attachment tube embodiments disclosedor contemplated herein can be incorporated into any of the advancementdevices disclosed or contemplated herein.

Alternatively, the various methods and devices disclosed or contemplatedherein can be used to assist in the advancement of any type of catheter,pre-shaped or otherwise. It is understood that while many of theexemplary embodiments disclosed herein discuss cardiovascular guidingcatheters, the various device implementations disclosed or contemplatedherein can be used with any guiding, delivery, or other type of catheteror sheath.

Although the various implementations have been described with referenceto preferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope thereof.

What is claimed is:
 1. A catheter advancement assistance device, thedevice comprising: (a) an elongate shaft; (b) a capsule fixedly attachedto a distal end of the elongate shaft, the capsule comprising: (i) aguidewire lumen defined through the capsule; (ii) an outer diametersubstantially similar to an inner diameter of a catheter such that thecapsule is sized to be positionable through the catheter; and (c) anattachment tube associated with a proximal portion of the elongateshaft.